Medical implant

ABSTRACT

A medical assembly includes an implant and an envelope at least partially enclosing a portion of the implant. The envelope may include a tongue to protect the implant, a scaffold to provide integrity to the envelope, a tab access to ease envelope withdrawal, and/or one or more discontinuities to ease envelope withdrawal.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/640,838 filed in the U.S. patent Office on Aug. 14, 2003, which isbased on and claims priority to provisional patent application Ser. No.60/403,555 filed in the U.S. Patent Office on Aug. 14, 2002 andprovisional patent application Ser. No. 60/449,465 filed in the U.S.Patent Office on Feb. 24, 2003. The entire contents of each of these twoprovisional applications are incorporated by reference herein. Thisapplication is a continuation-in-part application of U.S. patentapplication Ser. No. 10/093,371 filed in the U.S. Patent Office on Mar.7, 2002, now U.S. Pat. No. 6,991,597, U.S. patent application Ser. No.10/093,398 filed in the U.S. Patent Office on Mar. 7, 2002, U.S. patentapplication Ser. No. 10/093,424 filed in the U.S. Patent Office on Mar.7, 2002, now U.S. Pat. No. 6,936,052, U.S. patent application Ser. No.10/093,450 filed in the U.S. Patent Office on Mar. 7, 2002, U.S. patentapplication Ser. No. 10/093,498 filed in the U.S. Patent Office on Mar.7, 2002, now U.S. Pat. No. 7,025,772, and U.S. patent application Ser.No. 10/094,352 filed in the U.S. Patent Office on Mar. 7, 2002, now U.S.Pat. No. 7,235,043, which claim benefit of and priority to provisionalpatent application Ser. No. 60/274,843 filed in the U.S. Patent Officeon Mar. 9, 2001 and provisional patent application Ser. No. 60/286,863filed in the U.S. Patent Office on Apr. 26, 2001. The entire contents ofthese six nonprovisional applications are incorporated by referenceherein.

TECHNICAL FIELD

The invention relates generally to implanting a device such as asurgical sling at an anatomical site in the body of a mammal. Moreparticularly, the invention relates to delivering and placing thesurgical sling (entirely or partially within an envelope or a sheath) atan anatomical site in the body of a female patient or a male patient.

BACKGROUND INFORMATION

It is known to use a surgical sling to repair and restore living tissue.For example, surgical slings may be used to support and/or reinforce adamaged or weakened portion in the body of a patient. A sling used forsuch a purpose generally is made sufficiently porous to allow for growthof tissue through the mesh after implantation. The healing tissue growsthrough openings in, for example, an implanted synthetic mesh, therebyassimilating the tissue with the mesh and adding structural integrity tothe tissue.

Surgical slings may be produced with yarns including monofilament andmultifilament yarns. Multifilament yarns have small void areas orinterstitial spaces between the yarn filaments. The yarns in thesurgical sling may be made of materials such as polypropylene andpolyesters.

SUMMARY OF THE INVENTION

The crevices and voids of a surgical sling may harbor bacteria or otherpathogens that contaminate the surgical sling during implantation.Following implantation of the surgical sling in the patient, thebacteria or other pathogens harbored in the sling are introduced to theanatomical site where the sling is implanted. Typically, the anatomicalsite being repaired is poorly accessible to antimicrobial drugs appliedintraoperatively to combat bacteria or other pathogens that may bepicked up and introduced to the anatomical site during the surgery toimplant the mesh.

The invention relates to an implant, such as a surgical sling or mesh,for implantation at an anatomical site in the body of a patient, such asat the mid-urethra. The implant can be disposed within an envelope or asheath for delivery to and placement at the anatomical site, and such acombination (of an implant and an envelope) is referred to herein as animplant assembly. Implants and implant assemblies according to theinvention are relatively inexpensive, provide effective therapy, andrequire minimal training before use. Implants and implant assembliesaccording to the invention can be used to treat female urinaryincontinence, including stress incontinence, for example. The inventionalso relates generally to methods of making and using implants andimplant assemblies.

The invention, in one embodiment, addresses deficiencies in the priorart by providing an implant assembly that reduces or preventscontamination of the implant and contamination of the patient's tissueduring delivery of the implant assembly to the anatomical site. Anoperator can adjust and position the implant assembly at the anatomicalsite in the patient's body and maintain the correct position of theimplant at the anatomical site during and after withdrawal of anenvelope, which at least partially encloses the implant. Also, theimplant or implant assembly can be easily associated with a deliverydevice. The delivery device can be used to position the implant assembly(such as a sling in an envelope) at the patient's urethra. Transvaginal,transabdominal (e.g., percutaneous), supra-pubic, pre-pubic, ortransobturator approaches can be used to install and position theimplants and the implant assemblies. Without limitation, exemplarydelivery devices and methodologies that may be employed in combinationwith the implant assemblies of the invention can be found in U.S. patentapplication Ser. Nos. 10/093,498, 10/093,398, 10/093,450, 10/093,371,10/094,352, and 10/093,424 filed in the United States Patent Office onMar. 7, 2002, U.S. provisional patent application Ser. No. 60/418,827filed in the United States Patent Office Oct. 15, 2002, U.S. provisionalpatent application Ser. No. 60/418,642 filed in the United States PatentOffice Oct. 15, 2002, and U.S. provisional patent application Ser. No.60/434,167 filed in the United States Patent Office Dec. 17, 2002, thedisclosures of which are incorporated herein by reference.

The U.S. patent application Ser. No. 10/641,170 filed Aug. 14, 2003,entitled “Medical Slings” by Rao et al., the U.S. patent applicationSer. No. 10/642,395 filed Aug. 14, 2003, U.S. patent application Ser.No. 10/642,397 filed Aug. 14, 2003, U.S. patent application Ser. No.10/642,365 filed Aug. 14, 2003, and U.S. patent application Ser. No.10/641,487 filed Aug. 14, 2003, all entitled “Systems, Methods andDevices Relating to Delivery of Medical Implants” by Chu et al., theU.S. patent application Ser. No. 10/641,192 filed Aug. 14, 2003,entitled “Medical Slings” by Chu, the U.S. patent application Ser. No.10/641,376 filed Aug. 14, 2003, entitled “Spacer for Sling DeliverySystem” by Chu et al., and the Provisional patent application No.60/495,439 filed Aug. 14, 2003, entitled “Surgical Slings” by Li et al.are all filed on even date herewith and are incorporated herein byreference in their entirety.

In one aspect, the invention provides an assembly for delivering animplant to an anatomical location in a body. According to this aspect,the assembly includes an envelope having two sleeves. The two sleeves ofthe envelope enclose the implant, such as a sling for the treatment offemale urinary incontinence. In one embodiment, the assembly furtherincludes a scaffold. The scaffold is sized and shaped to be enclosedwithin a lumen of the envelope. The scaffold is configured to couple thefirst sleeve and the second sleeve together. In one embodiment, each ofthe sleeves of the envelope is about the same length. In anotherembodiment, the scaffold includes a fold to form a hinge between thefirst and second sleeves. The scaffold may be manufactured, for example,from rigid or flexible materials.

In another aspect of the invention, at least one sleeve of the envelopeincludes a tongue, which overlaps at least a portion of the implantenclosed within the envelope. In one embodiment of this aspect of theinvention, the tongue of the first sleeve is positioned within the lumenof the second sleeve. In some configurations, the tongue is an integralpart of at least one sleeve.

In another aspect, the assembly includes a tab joined to the envelope.The tab may be a positioning member for positioning the implant in thebody of the patient. In one embodiment of this aspect of the invention,the envelope includes a first sleeve section and a second sleeve sectionwhich interoperate to enclose at least a portion of the implant. A tabon the end of the first sleeve section is passed through the firstsleeve section to a first end of the envelope. A tab access foraccessing the tab is located at the first end of the envelope. The tabis accessible through the tab access to position the implant in thepatient's body. Similarly, a tab on the end of the second sleeve sectionis passed through the second sleeve section to a second end of theenvelope and the tab is accessible through a tab access located at thesecond end of the envelope. In one embodiment, the tab access is alinear cut through at least one sleeve from the outside of the sleeve,into the lumen of the sleeve. Alternatively, the tab access is aperforation or a series of perforations through the sleeve.

In another aspect, the assembly includes an envelope with one or moresleeves having a first side and a second side. The envelope encloses atleast a portion of an implant, for example, a sling having a length anda width. The first side of the envelope includes at least onediscontinuity that exposes the width along a first portion of the sling.In one embodiment, the discontinuity is a gap disposed between the firstand second portions of the first side of the envelope. The mid-lengthportion of the sling is devoid of covering (e.g., not enclosed) by theenvelope. This mid-length portion of the sling may be de-tanged. Inanother embodiment, the first side of the envelope has a firstslit-shaped aperture and a second slit-shaped aperture. The first andsecond slit-shaped apertures may be intermediately located along thelength of the sling. The sling that is at least partially enclosed bythe envelope threads out of the envelope through the first slit-shapedaperture and threads back into the envelope through the secondslit-shaped aperture, which creates a mid-length envelopeless sling loopthat is external to the envelope. The mid-length envelopeless sling loopmay be de-tanged and is devoid of covering, e.g., external to theenvelope.

Additional embodiments of the assembly according to the inventioninclude at least one loading member included on an end of an envelope.The loading member facilitates interoperability of the envelope with adelivery device. The loading member may be bonded to the implant, theenvelope, the scaffold, or some combination. The loading member may be,for example, a guide member, a guide tube, or some other type of male orfemale structure (such as a hook, loop, etc.) disposed at an end of theenvelope for mating with a complementary structure on the deliverydevice. At least one of the sleeves of the envelope may be manufacturedfrom a composite of two or more materials. In one embodiment, the twosleeves of the invention are joined by a hinge. The envelope of thedelivery device may include a visual indication mark, for example, aspacer, a clamp, a tinted area or other indication mark that provides avisual indication of the placement of the sling delivery device, i.e.,the envelope and/or implant. The visual indication may be employed toinform the operator about the orientation of, for example, the sling.

In another aspect, the invention relates to a method for delivering animplant assembly in a patient's body. In one embodiment, an assembly isprovided that includes an envelope having at least two sleeves thatenclose at least a portion of the implant. In a further embodiment, theassembly includes a scaffold that is sized and shaped to fit within thelumen of the envelope. In another embodiment of this aspect of theinvention, at least one of the sleeves has a tongue portion thatoverlaps the implant. In yet another embodiment, the assembly includesan envelope having at least one tab passed through a sleeve section toan end of the envelope and at least one tab access for accessing the tabthat is located at an end of the envelope.

In one embodiment, the implant assembly is positioned at the anatomicalsite in the patient's body. When the operator is satisfied with theposition of the implant assembly, the envelope is withdrawn from thepatient's body. The envelope may be withdrawn from the patient's body bypulling the tabs and pulling the hinge and the remaining portions of theenvelope from the body of the patient. Preferably, the implant assemblyis positioned at the mid urethra and a tab on a first sleeve section ofan envelope is pulled through the tab access on an end of the envelope.The pulled tab tears a portion of the envelope away from the implant anda hinge section is pulled intravaginally to withdraw the envelope from apatient's body. The envelope may also be withdrawn by cutting the tabaccesses, separating the envelope into two sides along the cut tabaccess, accessing the internal tabs, pulling the internal tabs, andpulling the hinge and remaining portions of the envelope intravaginallyfrom the body of the patient via the vagina. In another embodiment, theenvelope may be withdrawn by cutting the hinge section and separatingthe first sleeve from the second sleeve. Alternatively, the envelope maybe withdrawn by cutting the scaffold and separating the first sleevefrom the second sleeve. In another embodiment, the envelope may bewithdrawn by cutting and separating the external tabs or the loadingmembers, separating the first sleeve from the second sleeve andscaffold, separating the second sleeve from the scaffold, then pullingthe scaffold from the body of the patient. After withdrawal of theenvelope, the implant remains where it was positioned at the anatomicalsite, for example, at the mid-urethra of the patient to treat femaleurinary incontinence.

The foregoing and other objects, aspects, features, and advantages ofthe invention will become more apparent from the following descriptionand from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the sameparts throughout the different views. Also, the drawings are notnecessarily to scale, emphasis instead generally being placed uponillustrating the principles of the invention.

FIG. 1A illustrates one embodiment of an assembly for delivering animplant to a body.

FIG. 1B illustrates an embodiment of one of the sleeves illustrated inFIG. 1A.

FIG. 1C illustrates a cross section at 1C-1C of the embodiment of thesleeve illustrated in FIG. 1B.

FIG. 1D illustrates an embodiment of one of the sleeves illustrated inFIG. 1A.

FIG. 1E illustrates a cross section at 1E-1E of the embodiment of thesleeve illustrated in FIG. 1D.

FIG. 1F illustrates another embodiment of one of the sleeves illustratedin FIG. 1A.

FIG. 1G illustrates a cross section at 1G-1G of the embodiment of thesleeve illustrated in FIG. 1F.

FIG. 1H illustrates one embodiment of a method for making the assemblyfor delivering an implant to a body illustrated in FIG. 1A.

FIG. 1I illustrates a top view of one embodiment of an assembly fordelivering an implant to a body illustrated in FIG. 1A.

FIG. 1J illustrates one embodiment of a placement fork according to theinvention.

FIG. 1K illustrates a cross section at 1K-1K of an embodiment of theassembly for delivering an implant to a body illustrated in FIG. 1I.

FIG. 1L illustrates an embodiment of a portion of the assembly fordelivering an implant to a body illustrated in FIG. 1A.

FIG. 1M illustrates another embodiment of the assembly for delivering animplant to a body illustrated in FIG. 1A.

FIG. 2A illustrates another embodiment of an assembly for delivering animplant to a body.

FIG. 2B illustrates another embodiment of a portion of the assembly fordelivering an implant to a body illustrated in FIG. 2A.

FIG. 2C illustrates another embodiment of an assembly for delivering animplant to a body illustrated in FIG. 2A.

FIG. 3A illustrates one embodiment of an assembly for delivering animplant to a body.

FIGS. 3B-3G illustrate one embodiment of a method of making an assemblyfor delivering an implant to a body illustrated in FIG. 3A.

FIG. 3H illustrates a top view of one embodiment of the assembly fordelivering an implant to a body illustrated in FIG. 3A.

FIG. 3I illustrates a cross-section at 3I-3I of one embodiment of theassembly for delivering an implant to a body illustrated in FIG. 3H.

FIG. 4 illustrates another embodiment of an assembly for delivering animplant to a body.

FIG. 5A illustrates one embodiment of an assembly for delivering animplant to a body.

FIG. 5B illustrates a top view of one embodiment of a scaffold for usein the assembly illustrated in FIG. 5A for delivering an implant to abody.

FIG. 5C illustrates a side view of the scaffold illustrated in FIG. 5B.

FIG. 5D illustrates another embodiment of the scaffold for use in theassembly illustrated in FIG. 5A.

FIG. 5E illustrates another embodiment of one of the sleeves illustratedin FIG. 5A.

FIG. 5F illustrates another one of the sleeves for use in the assemblyillustrated in FIG. 5A for delivering an implant to a body.

FIG. 5G illustrates one embodiment of a method of making the assemblyfor delivering an implant to a body illustrated in FIG. 5A.

FIG. 5H illustrates a top view of one embodiment of the assembly fordelivering an implant to a body illustrated in FIG. 5A.

FIG. 5I illustrates a cross-section at 5I-5I of one embodiment of theassembly for delivering an implant to a body illustrated in FIG. 5H.

FIG. 6 illustrates a fragmented plan view of another embodiment of anassembly for delivering an implant to a body.

FIG. 7 illustrates a fragmented plan view of another embodiment of anassembly for delivering an implant to a body.

DESCRIPTION

In general, the invention described herein is an assembly for implantingan implant into the body of a patient. Referring to FIGS. 1A, 2A, 3A, 4,5A, 6, and 7 in one aspect, the assembly 120 includes an envelope 20enclosing an implant for example a sling 10. In accordance with theassembly 120 of the invention, an implant (for example, a surgical sling10 formed from a mesh or other suitable material) can be entirelysurrounded by or enclosed within the envelope 20, or only partiallycovered by the envelope 20.

In one embodiment according to the invention, the implant is a surgicalmesh. The surgical sling 10 may be fabricated from one or more yarns andthe yarns may be made from one or more materials. Materials that may beemployed include polypropylene, polyesters, polyolefins,polytetrafluoroethylene, polyethylene, polyurethanes, nylons, andco-polymers, without limitation such as those described in U.S. Pat. No.6,042,592, the entirety of which is incorporated by reference herein.The sling 10 may also be a hybrid of synthetic materials and tissues.The sling 10 may also be made from absorbable materials, such as,polyglycolic acid, polylactic acid and other suitable absorbablematerials. Exemplary slings 10 that may be employed with the inventionare described in, for example, U.S. patent application Ser. No.09/916,983 filed Jul. 27, 2001, provisional patent application Ser. No.60/388,109 filed Jun. 12, 2002, U.S. patent application Ser. No.10/460,112 filed Jun. 12, 2003, U.S. patent application Ser. No.10/092,872 filed Mar. 7, 2002, provisional patent application Ser. No.60/449,465 filed Feb. 24, 2003, and provisional patent application Ser.No. 60/465,722 filed Apr. 25, 2003 the entirety of all of which areincorporated by reference herein. Other exemplary slings 10 that may beemployed with the invention are described in the U.S. patent applicationSer. No. 10/641,170 filed Aug. 14, 2003, entitled “Medical Slings” byRao et al., and U.S. patent application Ser. No. 10/641,192 filed Aug.14, 2003, entitled “Medical Slings” by Chu, filed on even date herewith,the entirety of both of which are incorporated herein by reference.

The assembly 120 of the invention, which includes the envelope 20 andthe sling 10, may further include one ore more spacers (not shown).Exemplary spacers that may be employed with the invention are described,for example, in provisional patent application Ser. No. 60/434,167 filedDec. 17, 2002, provisional patent application Ser. No. 60/449,465 filedFeb. 24, 2003 and in the U.S. patent application Ser. No. 10/641,376,filed Aug. 14, 2003, entitled “Spacer for Sling Delivery System” by Chuet al. filed on even date herewith, the entirety of all of which areincorporated herein by reference.

Each of the one or more yarns used to make the sling 10 may include aplurality of filaments. Alternatively, a monofilament yarn may beemployed. In one embodiment, the sling 10 is formed from a mesh and themesh may be a polypropylene monofilament tricot mesh for use in surgicalapplications. Within the mesh, each yarn may have void areas betweenyarn filaments. The process used to fabricate the mesh may createcrevices in the mesh. Multifilament yarns have multiple voids orinterstitial spaces between the yarn filaments. Mesh, according to theinvention, may be produced according to a variety of fabricationprocesses known to the skilled artisan including, but not limited to,knitting, weaving, or braiding. Meshes fabricated using multifilamentyarns may have both crevices and interstitial voids. According to theillustrative embodiment of the invention, the surgical mesh is enclosedwithin the envelope 20 that entirely or partially surrounds the surgicalmesh. The envelope 20 surrounding the mesh reduces the likelihood thatthe mesh will become contaminated with foreign matter, such as bacteria,during mesh placement at an anatomical site in the body of the patient.

The illustrative envelopes 20 may be of varying construction, forexample, the envelope 20 may be used to assist in handling the sling 10and/or to assist in adjusting the sling 10 during surgical placement.The envelope 20 also aids in preventing the sling 10 from stretching orbecoming misshapen due to handling prior to placement at the anatomicalsite. The envelope 20 may be likened to a pouch or a sleeve thatpartially or entirely surrounds the sling 10. The thickness of thematerial used to make the envelope 20 may range from about 0.0001 inchto about 0.01 inch, preferably being about 0.0003 inch thick. In theillustrative embodiment, the envelope 20 defines a lumen 185 throughwhich at least a portion of the sling 10 can pass.

The material used to make the envelope 20 may be selected from the groupincluding polypropylene, polyethylene, polyester,polytetrafluoroethylene (e.g., TEFLON®), TYVEK®, MYLAR®, andco-polymers, thereof. In one embodiment according to the invention, thematerial used to make the envelope 20 is an absorbent material, such as,for example, a sponge-like material. The envelope 20 may be pre-soakedin a solution containing a drug such as an antibiotic prior to surgicalimplantation of the implant 10 in a patient's body.

In some configurations sling 10 is made of a non-wettable material suchas a polypropylene, polyethylene, polyester, polytetrafluoroethylene,TYVEK available from DuPont, PA, MYLAR available from DuPont, PA, orco-polymers thereof. Polytetrafluoroethylene, which is suitable for usein accordance with the present invention, is available from DuPont(Wilmington, Del., under the trade designation TEFLON). Suchnon-wettable materials do not take up any liquids, for example,therapeutic agents in solution.

To permit therapeutic agents to bond or absorb to these non-wettablematerial sides, the sling 10 may be treated with a substance that iswettable such as, for example, a wettable coating composition. Thewettable coating composition may be a synthetic coating (e.g.,polyvinylpyrrlidone or PVP), a natural coating (e.g., collagen) or aphysically absorbent material (e.g., sponge comprising cellulose or opencelled polyurethane). The wettable coating composition may behydrophilic. Suitable hydrophilic coatings may be water soluble andinclude, for example, such coatings available under the tradedesignations Hydroplus and Hydropass. Similarly, a hydrophobic coatingmay be employed on one or more surfaces of the sling 10. Suitablehydrophobic coatings that may be employed in accordance with theinvention include but are not limited to polytetrafluoroethylene,silicon, and Pyrelene.

Therapeutic agents may also be employed with sling 10. For example, thehydrophilic coating and the therapeutic agent are mixed to form a singlecoating. Alternatively, the therapeutic agents may be compressed intothe material of the sling 10, rather than being applied as a coating.

The therapeutic agents can be, for example, hydrophilic or hydrophobic.Hydrophilic drugs that may be employed in accordance with the inventioninclude oxybutynin chloride, lidocaine, ketorolac, ketorolactromethamine, which is available under the trade designation Toradolfrom Roche Pharmaceuticals (Nutley, N.J.) and hyoscyamine sulfate whichis available under the trade designation CYTOSPAZ from Polymedica(Woburn, Mass.), for example. Suitable hydrophobic drugs include but arenot limited to ibuprofen, ketoprofen, and diclofenac. The drug can bemixed with the coating and applied with the coating. Where the bondingbetween the coatings and drugs is weak, the drug that is absorbed willreadily release to be delivered to the sides it contacts. Alternatively,a stronger bonding affinity may provide a slower timed release of thedrug.

Where the coating applied to the surface of the sling 10 has an ioniccharge, drugs comprising a complementary charge will bond to the coatingwhen the coating and the drug are exposed to one another. The strengthof any bonding will impact how readily the drug is released from thesling 10. Where the ionic bonding between the coating and the drug isweak, the drug will release more readily. In embodiments where rapiddrug release is desirable, covalent bonding between the side coating andthe drug should be avoided.

hi general, the therapeutic agent for use in connection with the presentinvention can be any pharmaceutically acceptable therapeutic agent.Preferred therapeutic agents include anti-inflammatory agents, analgesicagents, local anesthetic agents, antispasmodic agents, and combinationsthereof.

Anti-inflammatory agents include steroidal and non-steroidalanti-inflammatory agents. Examples of non-steroidal anti-inflammatorydrugs, include aminoarylcarboxylic acid derivatives such as enfenamicacid, etofenamate, flufenamic acid, isonixin, meclofenamic acid,mefanamic acid, niflumic acid, talniflumate, terofenamate and tolfenamicacid; arylacetic acid derivatives such as acemetacin, alclofenac,amfenac, bufexamac, cinmetacin, clopirac, diclofenac sodium, etodolac,felbinac, fenclofenac, fenclorac, fenclozic acid, fentiazac,glucametacin, ibufenac, indomethacin, isofezolac, isoxepac, lonazolac,metiazinic acid, oxametacine, proglumetacin, sulindac, tiaramide,tolmetin and zomepirac; arylbutyric acid derivatives such as bumadizon,butibufen, fenbufen and xenbucin; arylcarboxylic acids such as clidanac,ketorolac and tinoridine; arylpropionic acid derivatives such asalminoprofen, benoxaprofen, bucloxic acid, carprofen, fenoprofen,flunoxaprofen, flurbiprofen, ibuprofen, ibuproxam, indoprofen,ketoprofen, loxoprofen, miroprofen, naproxen, oxaprozin, piketoprofen,pirprofen, pranoprofen, protizinic acid, suprofen and tiaprofenic acid;pyrazoles such as difenamizole and epirizole; pyrazolones such asapazone, benzpiperylon, feprazone, mofebutazone, morazone,oxyphenbutazone, phenybutazone, pipebuzone, propyphenazone,ramifenazone, suxibuzone and thiazolinobutazone; salicylic acidderivatives such as acetaminosalol, aspirin, benorylate, bromosaligenin,calcium acetylsalicylate, diflunisal, etersalate, fendosal, gentisicacid, glycol salicylate, imidazole salicylate, lysine acetylsalicylate,mesalamine, morpholine salicylate, 1-naphthyl salicylate, olsalazine,parsalmide, phenyl acetylsalicylate, phenyl salicylate, salacetamide,salicylamine o-acetic acid, salicylsulfuric acid, salsalate andsulfasalazine; thiazinecarboxamides such as droxicam, isoxicam,piroxicam and tenoxicam; others such as e-acetamidocaproic acid,s-adenosylmethionine, 3-amino-4-hydroxybutyric acid, amixetrine,bendazac, benzydamine, bucolome, difenpiramide, ditazol, emorfazone,guaiazulene, nabumetone, nimesulide, orgotein, oxaceprol, paranyline,perisoxal, pifoxime, proquazone, proxazole and tenidap; andpharmaceutically acceptable salts thereof.

Examples of steroidal anti-inflammatory agents (glucocorticoids) include21-acetoxyprefnenolone, aalclometasone, algestone, amicinonide,beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol,clobetasone, clocortolone, cloprednol, corticosterone, cortisone,cortivazol, deflazacort, desonide, desoximetasone, dexamethasone,diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort,flucloronide, flumehtasone, flunisolide, fluocinolone acetonide,fluocinonide, fluocortin butyl, fluocortolone, fluorometholone,fluperolone acetate, fluprednidene acetate, fluprednisolone,flurandrenolide, fluticasone propionate, formocortal, halcinonide,halobetasol priopionate, halometasone, halopredone acetate,hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone,medrysone, meprednisone, methyolprednisolone, mometasone furoate,paramethasone, prednicarbate, prednisolone, prednisolone25-diethylaminoacetate, prednisone sodium phosphate, prednisone,prednival, prednylidene, rimexolone, tixocortal, triamcinolone,triamcinolone acetonide, triamcinolone benetonide, triamcinolonehexacetonide, and pharmaceutically acceptable salts thereof.

Analgesic agents include narcotic and non-narcotic analgesics. Narcoticanalgesic agents include alfentanil, allylprodine, alphaprodine,anileridine, benzylmorphine, bezitramide, buprenorphine, butorphanol,clonitazene, codeine, codeine methyl bromide, codeine phosphate, codeinesulfate, desomorphine, dextromoramide, dezocine, diampromide,dihydrocodeine, dihydrocodeinone enol acetate, dihydromorphine,dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate,dipipanone, eptazocine, ethoheptazine, ethylmethlythiambutene,ethylmorphine, etonitazene, fentanyl, hydrocodone, hydromorphone,hydroxypethidine, isomethadone, ketobemidone, levorphanol, lofentanil,meperidine, meptazinol, metazocine, methadone hydrochloride, metopon,morphine, myrophine, nalbuphine, narceine, nicomorphine, norlevorphanol,normethadone, normorphine, norpipanone, opium, oxycodone, oxymorphone,papaveretum, pentazocine, phenadoxone, phenazocine, pheoperidine,piminodine, piritramide, proheptazine, promedol, properidine, propiram,propoxyphene, rumifentanil, sufentanil, tilidine, and pharmaceuticallyacceptable salts thereof.

Non-narcotic analgesics include aceclofenac, acetaminophen,acetaminosalol, acetanilide, acetylsalicylsalicylic acid, alclofenac,alminoprofen, aloxiprin, aluminum bis(acetylsalicylate),aminochlorthenoxazin, 2-amino-4-picoline, aminopropylon, aminopyrine,ammonium salicylate, amtolmetin guacil, antipyrine, antipyrinesalicylate, antrafenine, apazone, aspirin, benorylate, benoxaprofen,benzpiperylon, benzydamine, bermoprofen, brofenac, p-bromoacetanilide,5-bromosalicylic acid acetate, bucetin, bufexamac, bumadizon, butacetin,calcium acetylsalicylate, carbamazepine, carbiphene, carsalam,chloralantipyrine, chlorthenoxazin(e), choline salicylate, cinchophen,ciramadol, clometacin, cropropamide, crotethamide, dexoxadrol,difenamizole, diflunisal, dihydroxyaluminum acetylsalicylate,dipyrocetyl, dipyrone, emorfazone, enfenamic acid, epirizole,etersalate, ethenzamide, ethoxazene, etodolac, felbinac, fenoprofen,floctafenine, flufenamic acid, fluoresone, flupirtine, fluproquazone,flurbiprofen, fosfosal, gentisic acid, glafenine, ibufenac, imidazolesalicylate, indomethacin, indoprofen, isofezolac, isoladol, isonixin,ketoprofen, ketorolac, p-lactophenetide, lefetamine, loxoprofen, lysineacetylsalicylate, magnesium acetylsalicylate, methotrimeprazine,metofoline, miroprofen, morazone, morpholine salicylate, naproxen,nefopam, nifenazone, 5′ nitro-2′ propoxyacetanilide, parsalmide,perisoxal, phenacetin, phenazopyridine hydrochloride, phenocoll,phenopyrazone, phenyl acetylsalicylate, phenyl salicylate, phenyramidol,pipebuzone, piperylone, prodilidine, propacetamol, propyphenazone,proxazole, quinine salicylate, ramifenazone, rimazolium metilsulfate,salacetamide, salicin, salicylamide, salicylamide o-acetic acid,salicylsulfuric acid, salsalte, salverine, simetride, sodium salicylate,sulfamipyrine, suprofen, talniflumate, tenoxicam, terofenamate,tetradrine, tinoridine, tolfenamic acid, tolpronine, tramadol, viminol,xenbucin, zomepirac, and pharmaceutically acceptable salts thereof.

Local anesthetic agents include amucaine, amolanone, amylocainehydrochloride, benoxinate, benzocaine, betoxycaine, biphenamine,bupivacaine, butacaine, butaben, butanilicaine, butethamine,butoxycaine, carticaine, chloroprocaine hydrochloride, cocaethylene,cocaine, cyclomethycaine, dibucaine hydrochloride, dimethisoquin,dimethocaine, diperadon hydrochloride, dyclonine, ecgonidine, ecgonine,ethyl chloride, beta-eucaine, euprocin, fenalcomine, fomocaine,hexylcaine hydrochloride, hydroxytetracaine, isobutyl p-aminobenzoate,leucinocaine mesylate, levoxadrol, lidocaine, mepivacaine, meprylcaine,metabutoxycaine, methyl chloride, myrtecaine, naepaine, octacaine,orthocaine, oxethazaine, parethoxycaine, phenacaine hydrochloride,phenol, piperocaine, piridocaine, polidocanol, pramoxine, prilocaine,procaine, propanocaine, proparacaine, propipocaine, propoxycainehydrochloride, pseudococaine, pyrrocaine, ropavacaine, salicyl alcohol,tetracaine hydrochloride, tolycaine, trimecaine, zolamine, andpharmaceutically acceptable salts thereof.

Antispasmodic agents include alibendol, ambucetamide, aminopromazine,apoatropine, bevonium methyl sulfate, bietamiverine, butaverine,butropium bromide, n-butylscopolammonium bromide, caroverine,cimetropium bromide, cinnamedrine, clebopride, coniine hydrobromide,coniine hydrochloride, cyclonium iodide, difemerine, diisopromine,dioxaphetyl butyrate, diponium bromide, drofenine, emepronium bromide,ethaverine, feclemine, fenalamide, fenoverine, fenpiprane, fenpiveriniumbromide, fentonium bromide, flavoxate, flopropione, gluconic acid,guaiactamine, hydramitrazine, hymecromone, leiopyrrole, mebeverine,moxaverine, nafiverine, octamylamine, octaverine, oxybutynin chloride,pentapiperide, phenamacide hydrochloride, phloroglucinol, pinaveriumbromide, piperilate, pipoxolan hydrochloride, pramiverin, prifiniumbromide, properidine, propivane, propyromazine, prozapine, racefemine,rociverine, spasmolytol, stilonium iodide, sultroponium, tiemoniumiodide, tiquizium bromide, tiropramide, trepibutone, tricromyl,trifolium, trimebutine, n,n-1trimethyl-3,3-diphenyl-propylamine,tropenzile, trospium chloride, xenytropium bromide, and pharmaceuticallyacceptable salts thereof.

Two particularly preferred therapeutic agents for the practice of thepresent invention are (a) ketorolac and pharmaceutically acceptablesalts thereof (e.g., the tromethamine salt thereof, sold under thecommercial name Toradol®) and (b)4-diethylamino-2-butynylphenylcyclohexylglycolate and pharmaceuticallyacceptable salts thereof (e.g.,4-diethylamino-2-butynylphenylcyclohexylglycolate hydrochloride, alsoknown as oxybutynin chloride, sold under the commercial name Ditropan®).

The amount of the therapeutic agent present in the polymeric matrix isan amount effective to reduce the pain or discomfort associated with themedical device. Typically, the therapeutic agent is present in apolymeric matrix in a range from about 0.1% to about 30% by weight ofthe polymeric matrix (including 0.1%, 0.2%, 0.5%, 1%, 2%, 3%, 4%, 5%,6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%,21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30% and ranges between anytwo of these points, for instance, 0.1-10%, 10-20% and 20-30%, etc.).Where the oxybutynin chloride and ketorolac tromethamine are used arange of 2-20% is typical, more typically 5-15%.

Alternatively, other therapeutic agents as known to those in the fieldas useful to enhance the efficacy of the sling 10 or reduce adversereactions to the sling 10, for example, are contemplated with respect tothe invention.

After placing the envelope 20 and sling 10 combination at the anatomicalsite, the operator withdraws the envelope 20 from the patient's body.The method of envelope 20 withdrawal may vary according to the variousenvelope 20 constructions. In some embodiments, the envelope 20 may bewithdrawn from the body without being torn. In other embodiments, theoperator tears or cuts the envelope 20 prior to withdrawal.

In one illustrative embodiment, the envelope 20 of FIGS. 1A, 1H and 1Kincludes a first sleeve 20A, a second sleeve 20B, tabs 188, 198, tabaccesses 153A, 153B, 163A and 163B and the envelope hinge 200. The tabs188 and 198 are internal tabs enclosed within the envelope 20. The tab188 may be accessed from the inside of the envelope 20 and pulledoutside the envelope 20 via the tab access 153A. The envelope 20encloses the sling 10. The tab accesses 153A and 153B simplify accessingthe tabs 188 and 198 to enable withdrawal of envelope 20.

Referring to FIGS. 1B and 1C, sleeve 20A, includes an inner surface 30,an outer surface 40, a proximal end 154, a distal end 150, a first lumen185A, a tab 188 coupled to a top section 150A, and a bottom section150B. The sleeve 20A further includes the tab access 153A.

As shown in FIGS. 1B-1E, the tab access 153A and 153B may be one or morecuts 220A and 230A, respectively, disposed through a surface or atearable region 222A of a sleeve 20A of envelope 20. The tearable region222A includes a material that is easily torn open. Such easily tornmaterials include, but are not limited to, a material with a molecularorientation such as a linear low density polyethylene or linearpolytetrafluoroethylene. The envelope 20 may be manufactured partiallyor entirely from these materials. For example, the envelope 20 mayinclude sections including linear low density polyethylene along withsections including a series of perforations, cuts or apertures.Referring to FIGS. 1A, 1D and 1F, the envelope 20 includes a tearableregion 222A and 222B with tabs 188 and 198, respectively, that may betorn away.

In one illustrative embodiment, referring again to FIGS. 1B-1D, the tabaccess 153A is formed from one or more perforations, apertures or cuts220A that are disposed lengthwise along the length of the top surface250A of the first sleeve 20A of envelope 20. In another exemplaryembodiment (not shown) the tab access 153A may be placed transverse orat another angle relative to the length of a sleeve 20A of envelope 20.

In one illustrative embodiment, illustrated in FIGS. 1B-1D the tabaccess 153A includes the series of cuts 220A disposed on the top surface250A along the length of sleeve 20A between one aperture, a first hole151A, and another aperture, a second hole 152A. In another illustrativeembodiment, the tab access 153B includes the series of cuts 230Adisposed on the bottom surface 250B between one aperture, the first hole151B, and another aperture, the second hole 152B. The diameter of theholes 151A, 152A, 151B and 152B may range between about 1/64 inches andabout ¼ inches, preferably being about 3/32 inches. In the illustrativeembodiment, the sleeve 20A top surface 250A and bottom surface 250B havetab accesses 153A and 153B respectively. In another embodiment, eitherthe top surface 250A or the bottom surface 250B of sleeve 20A has a tabaccess 153A or 153B.

FIGS. 1A, 1D and 1E illustrate another illustrative embodiment of thesleeve 20A of assembly 120. The tab 188 is coupled to the top section150A and pulled into the first lumen 185A of sleeve 20A. In oneillustrative embodiment, the tab 188 is positioned in the first lumen185A between the first hole 151A and the second hole 152A of tab access153A. In one embodiment, sleeve 20A has two first holes 151A and 151B,two second holes 152A and 152B, and the tab 188. Referring now to FIG.1E, the first holes 151A and 151B may be positioned between about 0.5inch to about 2 inches, preferably about 1.5 inches from the proximalend 154 of sleeve 20A. Each of the first holes 151A and 151B may bepositioned at the same distance, or, alternatively, at differentdistances from the proximal end 154. The second holes 152A and 152B maybe positioned between about 0.05 inch to about 1 inch, preferably about0.5 inch from the proximal end 154 of sleeve 20A. Each of the secondholes 152A and 152B may be positioned at the same distance, or,alternatively, at different distances from the proximal end 154. The tab188 that is coupled to top section 150A and pulled into the first lumen185A of sleeve 20A may be positioned between about 0.25 inch to about1.75 inch, preferably about 1 inch from the proximal end 154 of sleeve20A.

FIG. 1F illustrates a second sleeve 20B of the envelope 20 shown in FIG.1A. For example, FIGS. 1F and 1G illustrate the sleeve 20B including aninner surface 30, an outer surface 40, a proximal end 160, a distal end164, a second lumen 185B, a tab 198 coupled to a top section 160A, and abottom section 160B. The sleeve 20B further includes the tab accesses163A and 163B. The tab access 163A is formed from one or moreperforations, apertures or cuts 220B disposed lengthwise along thelength of the top surface 260A of sleeve 20B. Similarly, the tab access163B is formed from one or more perforations, apertures or cuts 230Bthat are disposed lengthwise along the length of the bottom surface 260Bof sleeve 20B. The tab accesses 163A and 163B may be placed transverseor at another angle relative to the length of sleeve 20B of envelope 20.

In one illustrative embodiment, the tab access 163A includes a series ofcuts 220B disposed on the top surface 260A lengthwise along the lengthof sleeve 20B between one aperture, a first hole 161A, and anotheraperture, a second hole 162A. The tab access 163B includes a series ofcuts 230B disposed on the bottom surface 260B lengthwise along thelength of sleeve 20B between one aperture, a first hole 161B, andanother aperture, a second hole 162B. The diameter of the holes 161A,162A, 161B and 162B may range between about 1/64 inches and about ¼inches, preferably about 3/32 inches. In one embodiment, either the topsurface 260A or the bottom surface 260B of sleeve 20B has a tab access163A or 163B. In another embodiment, the tab 198 is coupled to the topsection 160A and is pulled into the second lumen 185B of sleeve 20B suchthat the tab 198 is positioned in the second lumen 185B between thefirst holes 161A and 161B and the second holes 162A and 162B.

FIGS. 1F and 1G illustrate the sleeve 20B having two first holes 161Aand 161B, two second holes 162A and 162B and the tab 198. Referring nowto FIG. 1G, the first holes 161A and 161B may be positioned betweenabout 0.5 inch to about 2 inches, preferably about 1.5 inches from thedistal end 164 of sleeve 20B. Each of the first holes 161A and 161B maybe positioned at the same distance, or, alternatively, at differentdistances from the distal end 164 of sleeve 20B. The second holes 162Aand 162B may be positioned between about 0.05 inch to about 1 inch,preferably about 0.5 inch from the distal end 164 of sleeve 20B. Each ofthe second holes 162A and 162B may be positioned at the same distance,or, alternatively, at different distances from the distal end 164. Thetab 198 that is coupled to top section 160A and pulled into the secondlumen 185B of sleeve 20B may be positioned between the first holes 161Aand 161B and the second holes 162A and 162B. In one embodiment, the tab198 is positioned between about 0.25 inch to about 1.75 inch, preferably1 inch from the distal end 164 of sleeve 20B. Referring now to FIGS. 1A,1H, and 1K, the tab accesses 153A and 153B are positioned at the firstend 201 of the envelope 20 and the tab accesses 163A and 163B arepositioned at the second end 202 of envelope 20.

Referring now to FIG. 1H, the bottom section 150B of the first sleeve20A is placed at about a 90° angle relative to the length of the firstsleeve 20A. Similarly, the bottom section 160B of the second sleeve 20Bis placed at about a 90° angle relative to the length of the secondsleeve 20B. The sleeves 20A and 20B are aligned in proximity to oneanother such that the bottom sections 150B and 160B of sleeves 20A and20B, respectively, face one another. Referring now to FIGS. 1A and 1K,the bottom sections 150B and 160B act as hinge sections when the bottomsections 150B and 160B are joined to one another by adhesive, staples,heat bonding or other means known to the skilled person to form hinge200. In one embodiment, a clip (not shown) may be employed to join thebottom sections 150B and 160B, forming hinge 200.

As shown in FIG. 1I, the sleeves 20A and 20B form envelope 20 and theproximal end 154 of first sleeve 20A is positioned on the opposite endfrom the distal end 164 of the second sleeve 20B. The tab access 153A islocated at a first end 201 of the envelope 20 and the tab access 163A islocated at the second end 202 of the envelope 20. The tabs 188 and 198are located at the first end 201 and the second end 202, respectively,of the envelope 20. The tab 188 is passed through the lumen 185A ofsleeve 20A and is placed at the first end 201 of envelope 20 about theregion of the tab access 153A and the tab 198 is passed through thelumen 185B of sleeve 20B and is placed at the second end 202 of envelope20 about the region of the tab access 163A. Referring again to FIG. 1K,the bottom sections 150B and 160B of sleeve 20A and sleeve 20B form thehinge 200 of the envelope 20. The envelope 20 has a proximal end 154 anda distal end 164, formed by the proximal end 154 and distal end 164 ofsleeves 20A and 20B, respectively. Referring again to FIG. 1I, thelength of envelope 20, from the proximal end 154 to the distal end 164ranges between about 4.0 inches to about 28.0 inches, or between about12.0 inches and about 24.0 inches, most preferably 20.0 inches.

Referring now to FIGS. 1D, 1F and 1K, in a particular embodiment, thetop section 150A is not fully pulled into the sleeve 20A, such that anoverlap region 150C of the top section 150A remains on the outer surface40. Similarly, the top section 160A of sleeve 20B is not fully pulledinto the sleeve 20B, such that an overlap region 160C of top section160A remains on the outer surface 40. The overlap regions 150C and 160Crange between about 0.04 inches to about 1.2 inches, preferably about0.3 inches. The overlap region 160C of sleeve 20B of envelope 20 may layon top of the overlap region 150C of sleeve 20A of envelope 20. Theoverlap regions 150C and 160C protect the sling 10 enclosed withinenvelope 20. For example, in embodiments of the invention where theenvelope 20 is employed to implant a mid-urethral sling 10, the overlapregions 150C and 160C of the envelope 20 prevents the sling 10 fromstretching caused by, for example, a hemostat inadvertently applied tothe sling 10 during surgery.

In one embodiment, referring now to FIGS. 1D, 1F and 1K, the tabaccesses, 153A, 153B, 163A and 163B or a portion of a tab access, forexample one or more hole 151A, 152A, 151B and 152B and/or one or morecut 220A, 220B, 230A, and 230B may be employed to sterilize envelope 20and/or the sling 10 enclosed therein. In one embodiment, ethylene oxide(ETO) gas is supplied to the lumen 185 of envelope 20 through a portionof or the entire tab access 153A, 153B, 163A or 163B. In oneillustrative embodiment, ETO is be supplied into the first hole 151B ofenvelope 20 prior to operator placement inside the patient's body.

In one illustrative embodiment, referring now to FIG. 1J, a placementfork 170 is employed to position an implant, such as a sling 10, withinenvelope 20. The placement fork 170 has a fork handle 173 and forkprongs 171. In one embodiment, the placement fork 170 has one or morefork prongs 171. In another embodiment, the placement fork 170 has twoor more fork prongs 171. The fork prongs 171 may be configured to have apointed end 175. Alternatively, the fork prongs 171 may be configuredwith a flat end 175. In one embodiment, the fork prongs 171 areconfigured with a rounded end 175. In other embodiments, a fork prong171 has a sharp end 175 or a dull end 175. Placement forks 170 may havemultiple fork prongs 171 having different configurations.

In one embodiment, referring to FIGS. 1I, 1J and 1K, the placement fork171 is employed to place a sling 10 for treatment of female urinaryincontinence in sleeves 20A and 20B of envelope 20. Each of sleeves 20Aand 20B measure 9.75 inches and the sling 10 measures 18 inches. Thelength of each fork prong 171 may range from about 0.300 inch to about0.400 inch, preferably about 0.350 inch long. The diameter of each forkprong 171 may measure between about 0.028 inch to about 0.040 inch,preferably about 0.030 inch. In one embodiment, there are two forkprongs 171 on the placement fork 170. In another embodiment, each forkprong 171 is spaced from about 0.090 inch to about 0.110 inch,preferably about 0.100 inch from the adjacent fork prong 171 on theplacement fork 170. In one embodiment, the fork prongs 171 have roundedends 175. The fork handle 173 length may range from about 10 inches toabout 12 inches, preferably about 11 inches long.

The placement fork 170, including the handle 173 and fork prongs 171,may be configured to fit within the lumen 185 of envelope 20. The forkhandle 173 and the fork prongs 171 of the placement fork 170 may befabricated from various materials, including medical grade stainlesssteel, for example 304 stainless tool steel, or medical grade plastic,for example nylon or TEFLON®. In one embodiment, a material, such as asoft plastic, may be employed to cover the placement fork 170 handle 173to provide ease of gripping and/or comfort to the operator using theplacement fork 170.

Optionally, referring still to FIGS. 1J and 1K, when placing a sling 10,the overlap region 160C is pulled in the direction perpendicular to theenvelope 20 and the overlap region 150C is pulled out of the lumen 185Bof second sleeve 20B in the direction perpendicular to the envelope 20.The placement fork 170 may be held by the fork handle 173. The forkprongs 171 may be used to position the sling 10 inside envelope 20. Theplacement fork 170 may have one or more fork prongs 171. In oneembodiment, the positioning fork 170 has two fork prongs 171.

In one illustrative embodiment, the implant, a sling 10, is pierced bythe fork prongs 171 and positioned in the lumen 185B of second sleeve20B of envelope 20. Thereafter, the sling 10 is positioned in the lumen185A of first sleeve 20A of envelope 20. In another embodiment, theprongs 171 of the placement fork 170 are employed to position the sling10 within the lumen 185B of the second sleeve 20B and within the lumen185A of the first sleeve 20A, without piercing the sling 10. To ensureproper sling 10 placement within the lumen(s) 185A and 185B of thesleeves 20A and 20B, respectively, the length of the handle 173 ofplacement fork 170 may be selected according to the combined lengths ofthe sleeves 20A and 20B.

Referring again to FIG. 1K, the overlap regions 150C and 160C, cover thesling 10 enclosed within envelope 20. In another illustrative embodimentaccording to the invention, referring to FIG. 1K, the sling 10 is placedwithin the envelope 20 after the bottom sections 150B and 160B ofsleeves 20A and 20B are joined to form hinge 200. Referring now to FIG.1A, the tabs 208 and 218 are joined to the envelope 20 after the hinge200 is formed. The tabs 208 and 218 are external to the envelope 20 andthey are positioning members for positioning the envelope 20 inside thebody of the patient. The tabs 208 and 218 are positioned at the proximalend 154 and the distal end 164 of envelope 20, respectively. Theimplant, for example the sling 10, may be manually inserted into lumen185 of envelope 20. Alternatively, the sling 10 may be inserted intolumen 185 with the aid of a placement fork 170 described above withreference to FIG. 1J.

In another illustrative embodiment, referring to FIGS. 1K and 1J, thesling 10 is manually placed within the first lumen 185A of the firstsleeve 20A and/or placed with the aid of the placement fork 170 or agrasping device, such as, for example, forceps. Thereafter, sleeve 20Bis joined with the sleeve 20A to form the envelope 20, including thehinge 200. The remaining portion of the sling 10 may be placed withinthe second lumen 185B of sleeve 20B prior to or after forming the hinge200.

In yet another embodiment, referring to FIGS. 1D, 1F and 1K the sling 10is placed, via the tab accesses, 153A, 153B, 163A, and 163B, within theenvelope 20 after the sleeves 20A and 20B are joined at hinge 200.According to this embodiment, referring also to FIGS. 1A and 1J, thesling 10 is inserted into, for example, cut 230B of tab access 163Bmanually and/or with the aid of a grasping device or the placement fork170 and the sling 10 is positioned within lumen 185. In anotherembodiment, the sling 10 is placed within the envelope 20 via the tabaccesses, 153A, 153B, 163A, and/or 163B after the sleeves 20A and 20Bare joined at hinge 200, and after tabs 208 and 218 are joined to theenvelope 20.

With reference to FIGS. 1L-1M, in another aspect the invention includesa method for positioning the sling 10 at an anatomical site in the bodyof a patient. According to one embodiment of this method of theinvention, the operator positions the assembly 120 of the envelope 20enclosing sling 10 at the anatomical site, for example, the urethra 999or bladderneck of a female patient. Referring to FIG. 1L, the tab 188and the tab access 153A are located at the first end 201 of theenvelope. The operator accesses the tab 188 by pulling tab 188 throughcut 220A of tab access 153A. Referring to FIG. 1M, the operatorintravaginally grasps hinge 200 and simultaneously pulls the tab 188 inthe direction indicated by arrow 189. The force exerted on tab 188coupled to the top section 150A tears the envelope 20 along the topsurface 250A of the first sleeve 20A. Thereafter, the top section 150Aof sleeve 20A is torn away from the envelope 20 in a single piece toexpose the implant sling 10. Tab 188, the top section 150A, the top ofsleeve 20A, and a portion of the proximal top section 154A are torn awayfrom the envelope 20 and the implant sling 10 is exposed. The exposedportion of the sling 10 is adjacent the urethra 999.

Referring again to FIGS. 1A, 1F, 1I, 1K, and 1M, the operator similarlyaccesses tab 198 by pulling tab 198 through cut 220B of tab access.163A. The tab 198 and the tab access 163A are located at the second end202 of the envelope 20. The operator intravaginally grasps hinge 200 andsimultaneously pulls tab 198. The force exerted on tab 198 coupled tothe top section 160A tears the envelope 20 along the top surface 260A ofthe sleeve 20B away from the envelope 20. The force exerted on tab 198coupled to the top section 160A tears these portions of sleeve 20B awayfrom the envelope 20. Thus, tab 198, the top section 160A, the top ofsleeve 20B, and a portion of the distal top section 164A are withdrawnfrom envelope 20. The portion of the sling 10 previously enclosed by theenvelope 20 is thereby exposed. Finally, the hinge 200 and the remainderof envelope 20 including the tabs 208 and 218 are withdrawn via thepatient's vagina. The sling 10 remains inside the body of the patient atthe anatomical site where the operator positioned the sling 10, forexample, at the anatomical site of the urethra 999.

In another illustrative embodiment, FIGS. 2A-2C illustrate the envelope20, described in accordance with FIGS. 1A-1M, further including a firstguide tube 350A and a second guide tube 350B. As illustrated in FIGS. 1Kand 2A the assembly 120 includes the envelope 20 including first sleeve20A, second sleeve 20B, tabs 188, 198, tab accesses 153A, 153B, 163A,and 163B, the envelope hinge 200, the envelope 20 enclosing all or partof sling 10. A first guide tube 350A is coupled to the proximal end 154of first sleeve 20A and the second guide tube 350B is coupled to thedistal end 164 of the second sleeve 20B of envelope 20. The first guidetube 350A, the proximal end 154, and the tab access 153A and the secondguide tube 350B, the distal end 164, and the tab access 163A arepositioned on opposite ends of the envelope 20 formed by sleeve 20A andsleeve 20B. The tab access 153A and 153B are positioned at the first end201 of the envelope 20 and the tab accesses 163A and 163B are positionedat the second end 202 of the envelope 20.

The guide tubes 350A and 350B facilitate interoperability of theassembly 120 with a delivery device. Other structures that facilitateinteroperability of the assembly 120 with a delivery device to introducethe assembly 120 to the body of the patient may be employed inaccordance with the assembly 120 of the invention. Suitableconfigurations and structures include, for example, loops, apertures,male and/or female connectors, guide tubes and the like. Such otherstructures that may be employed are described in more detail in the U.S.patent application Ser. Nos. 10/093,371, 10/093,398, 10/093,424,10/093,450, 10/093,498, and 10/094,352 filed in the United States PatentOffice on Mar. 7, 2002, which are based on and claim priority toprovisional patent application Ser. No. 60/274,843 filed in the UnitedStates Patent Office on Mar. 9, 2001 and provisional patent applicationSer. No. 60/286,863 filed in the United States Patent Office on Apr. 26,2001, provisional patent application Ser. No. 60/418,827 filed in theUnited States Patent Office on Oct. 15, 2002, provisional patentapplication Ser. No. 60/418,642 filed in the United States Patent Officeon Oct. 15, 2002, provisional patent application Ser. No. 60/434,167filed in the United States Patent Office on Dec. 17, 2002, U.S. patentapplication Ser. No. 10/325,125 filed Dec. 19, 2002, provisional patentapplication Ser. No. 60/449,465 filed in the United States Patent Officeon Feb. 24, 2003, provisional patent application Ser. No. 60/465,722filed in the United States Patent Office on Apr. 25, 2003, and U.S.patent application Ser. No. 10/832,653 filed Apr. 26, 2004, entitled“Systems and Methods for Sling Delivery and Placement” by Chu et al.filed on even date herewith, the entirety of all of which areincorporated herein by reference.

Referring to FIGS. 2A-2C, the operator may employ the assembly 120 ofthe invention to position the implant at an anatomical site in the bodyof a patient. The operator will employ the first and second guide tube350A and 350B to position the envelope 20 enclosing sling 10 at ananatomical site in the body of a patient. Other structures as describedand incorporated herein above may be used to position the envelope 20enclosing sling 10 at an anatomical site in the body of a patient. Theenvelope 20 may be positioned with the aid of a delivery device that maybe employed to access the patient's urethra 999 according tosupra-pubic, pre-pubic, transvaginal, or transobturator approaches. Theoperator positions the envelope 20 enclosing sling 10, at the anatomicalsite, for example, the urethra 999 or bladderneck. Referring to FIG. 2B,the operator accesses the tab 188 by pulling tab 188 through cut 220A oftab access 153A. Referring to FIG. 2C, the operator intravaginallygrasps hinge 200 and simultaneously pulls the tab 188 in the directionindicated by arrow 189. The force on tab 188 coupled to the top section150A tears the envelope 20 along the top portion of the first sleeve20A. Thereafter, the top section 150A of sleeve 20A is torn away fromthe envelope 20 in a single piece to expose the implant sling 10. Tab188, the top section 150A, the top surface 250A of sleeve 20A, and aportion of the proximal top section 154A are torn away from the envelope20 and the implant sling 10 is exposed. The exposed portion of the sling10 is adjacent the urethra 999.

Referring now to FIGS. 1K, 1F and 2C, the operator similarly accessestab 198 by pulling tab 198 through cut 220B of tab access 163A. Theoperator intravaginally grasps hinge 200 and simultaneously pulls tab198. The force exerted on tab 198 coupled to the top section 160A tearsthese portions of sleeve 20B away from the envelope 20. Thus, tab 198,the top section 160A, the top surface 260A of sleeve 20B, and a portionof the distal top section 164A are withdrawn from envelope 20. Theportion of the sling 10 previously enclosed is thereby exposed. Finally,the hinge 200 and the remainder of envelope 20 including the first guidetube 350A and the guide tube 350B are withdrawn via the patient'svagina. The sling 10 remains inside the body of the patient at theanatomical site where the operator positioned the sling 10, for example,at the anatomical site of the urethra 999.

Referring now to FIGS. 1D, 2B and 2C, in another illustrativeembodiment, the tab accesses 153A and 153B include perforations (notshown) about the perimeter of the perpendicular axis 24A of sleeve 20Aof envelope 20. The operator can access the tab 188 by grasping andwithdrawing, for example, the guide tube 350A and the portion of theenvelope 20 lying between the perforation and the envelope 20 proximalend 154. The tab 188 is thereby exposed and is accessible to theoperator. In one embodiment, the envelope 20 tab access 153A hasperforations about the perimeter of the perpendicular axis 24A ofenvelope 20 and also has a nick (not shown) at one or more portions ofthe perforated perimeter that enables the tab access 153A to be pulledor torn to expose the tab 188 enclosed within the envelope 20.

In yet another embodiment, referring now to FIGS. 1I, 1K, and 2A the tabaccess 153A and 153B includes shapes (not shown) cut out of one or moreof the top surfaces 250A, 260A and bottom surfaces 250B, 260B of sleeves20A and 20B, respectively. Suitable cut out shapes include, oval andtriangle, and the triangular cut out shape may have, for example,rounded edges.

Referring now to FIGS. 1D, 1F, and 2A, in one illustrative embodimentfor positioning the assembly 120 in the body of a patient, the envelope20 enclosing an sling 10 is positioned inside the body of a patient. Thetab access 153A, including a cut 220A disposed between the first hole151A and the second hole 152A, and the tab access 153B, including a cut230A disposed between the first hole 151B and the second hole 152B, arecut at position 437A. The cut at position 437A cuts through the secondholes 152A and 152B. The guide tube 350A and a portion of the envelopematerial are withdrawn. Thereafter, the sides of envelope 20 sleeve 20Aare pulled apart by opening and separating each of the cuts 220A and230A. In one embodiment, the sides of envelope 20 separate until thepoint where the first holes 151A and 151B are located. The first holes151A and 151B may provide, for example, relief to the cuts 220A and230A.

In another illustrative embodiment, tab accesses 163A, 163B on sleeve20B are cut at position 437B and tab 198 is similarly accessed byseparating the sides of the envelope 20. The guide tube 350B and aportion of the envelope are withdrawn.

According to this embodiment, after the sling 10 is positioned, theoperator cuts the envelope 20 at position 437A, withdraws the firstguide tube 350A, and separates the envelope 20 to provide accesses tothe tab 188. The operator intravaginally grasps hinge 200 andsimultaneously pulls the tab 188 and the force on tab 188 coupled to thetop section 150A tears the envelope 20 along the top portion of thefirst sleeve 20A. The top section 150A of sleeve 20A is torn away fromthe envelope 20 in a single piece to expose the implant sling 10. Tab188, the top section 150A, the top surface 250A of sleeve 20A, and aportion of the proximal top section 154A are torn away from the envelope20 and the implant sling 10 is exposed. The exposed portion of the sling10 is adjacent the anatomical site

The operator cuts the envelope 20 at position 437B, withdraws the secondguide tube 350B, and separates the envelope 20 to provide accesses tothe tab 198. The operator grasps hinge 200 and simultaneously pulls tab198. The force exerted on tab 198 coupled to the top section 160A tearsthese portions of sleeve 20B away from the envelope 20. Thus, tab 198,the top section 160A, the top surface 260A of sleeve 20B, and a portionof the distal top section 164A are withdrawn from envelope 20. Theportion of the sling 10 previously enclosed is thereby exposed. Finally,the hinge 200 and the remainder of envelope 20 are withdrawn via thevagina. This embodiment avoids guide tubes 350A and 350B being pulledback through the patient's body when the operator withdraws theremainder of the envelope. The sling 10 remains inside the body of thepatient at the anatomical site where the operator positioned the sling10.

Referring again to FIG. 2A, in another embodiment, the tab access 153Aand 153B is a cut out shape, for example, an oval (not shown). In oneembodiment, the cut out oval may be cut over positions 437A and 437B.When the operator cuts positions 437A, 437B withdrawing a portion of theenvelope 20 and first guide tube 350A and a portion of the envelope 20and a second guide tube 350B. The portion of the envelope 20 belowpositions 437A and 437B may be separated until the point at the bottomof the oval, providing access to the tabs 188, 198 enclosed within theenvelope 20.

In another aspect, the invention includes an assembly 120 for deliveringthe envelope 20 and an implant, for example, a sling 10 to an anatomicalsite in the body of a patient. In one embodiment, shown in FIG. 3A, theassembly 120 includes the envelope 20 including two or more sleeves 20A,20B, one or more tabs 208, 218 and a tongue 155. The tongue 155simplifies placement and/or withdrawal of the envelope 20 from insidethe body of the patient and prevents damage to the sling 10 therebymaintaining the integrity of the sling 10 enclosed by the envelope 20.

Referring to FIG. 3D, generally, the tongue 155 is an extension of thetop section 150A of the sleeve 20A. The tongue 155 extends from one endof the sleeve 20A. In one embodiment, the tongue 155 is separate, i.e.,non-contiguous with the bottom section 150B of the sleeve 20A. Inanother embodiment, tongue 155 extends from the top section 150A beyondthe lumen 185A of the sleeve 20A. The tongue may be flexible and it maybe any flat shape, for example, rectangular or oval. The length of thetongue measures between about 0.2 inches and about 5 inches, preferablyabout 1 inch in length. The width of the tongue measures between about0.1 inches and about 2.0 inches. The thickness of the tongue 155 is atleast as thick as the sleeve from which the tongue is made. In anotherembodiment, the tongue 155 is bonded at an end of sleeve 20A, in suchembodiments the tongue 155 thickness may be greater, less, or equal tothe thickness of the sleeve 20A to which the tongue 155 is bonded. Thetongue 155 may be bonded to sleeve 20A by adhesives, sutures, or heatbonding as well as by other bonding means known to the skilled person.

Referring now to FIG. 3B, in one embodiment of the invention, the tongueis made by cutting two angles into the first sleeve 20A, as indicated bythe arrow 176 and arrow 178. The angles 176 and 178 are cut in the rangeof from about 40° to about 170°, or about 80° to about 130°, preferablyabout 110°, from the longitudinal axis 22A of the sleeve 20A illustratedin FIG. 3B. Preferably, the angles 176 and 178 are obtuse, ranging fromgreater than 90° to about 130° as measured from the longitudinal axis22A on the side of the distal end 150 of the sleeve 20A. In oneembodiment, the two angles 176 and 178 are cut into the first sleeve 20Afor a distance between about 0.01 inch and about 0.05 inch, preferablyabout 0.04 inch into the sleeve 20A as measured along the perpendicularaxis 24A. Referring now to FIGS. 3A and 3D, the angles 176 and 178 andthe depth of the cut into the sleeve 20A along the perpendicular axis24A at which the angles 176 and 178 are placed, determines the placementof tongue 155 of envelope 20, by, for example, sizing or placing thetongue 155 to cover the sling 10 enclosed by envelope 20.

Referring to FIG. 3C, the distal end portion 150 of sleeve 20A istrimmed along the longitudinal axis 22A from the distal end 150 to angle176 and from the distal end 150 to the angle 178. In general, the amountof the first sleeve 20A that is trimmed along the longitudinal axis 22Afrom the distal end 150 to each respective angle 176 and 178 issubstantially the same. The first sleeve 20A has a first lumen 185A, andits structure is tube-like, and after the first sleeve 20A is trimmed,the distal end 150 portion has a top section 150A and a bottom section150B. After the first sleeve 20A is trimmed, the longitudinal axis 22Aof first sleeve 20A from the angle 178 to the end 150 of top section150A, may measure between about 2.0 inches to about 14.0 inches,preferably about 10.0 inches. As illustrated in FIG. 3D, the top section150A is trimmed along the perpendicular axis 24A forming a tongue 155which measures between about 0.2 inches and about 5 inches, preferablyabout 1 inch in length as measured along the longitudinal axis 22A ofenvelope 20. The envelope 20 may be trimmed by employing, for example, arazor. The width of the tongue 155 measured along the perpendicular axis24A of envelope 20, is sized so that it is equal to or smaller than theinner diameter of a second lumen 185B of the second sleeve 20B ofenvelope 20, illustrated in FIG. 3F. For example, the width of thetongue 155 may measure between about 0.1 inches and about 2.0 inches.

Referring now to FIGS. 3E and 3F, the second sleeve 20B of the envelope20 shown in FIG. 3A is illustrated. Referring to FIG. 3E, the secondsleeve 20B has the inner surface 30, the outer surface 40, the proximalend 160, and the distal end 164. The second sleeve 20B includes thesecond lumen 185B. The length of the second sleeve 20B between theproximal end 160 and the distal end 164, along the longitudinal axis22B, is between about 4.0 inches and about 28.0 inches, preferably about20.0 inches. The perpendicular axis 24B of second sleeve 20B measuresbetween about 0.2 inches to about 2.0 inches, preferably between about0.4 inches and about 0.8 inches, preferably about 0.6 inches.

Still referring to FIG. 3E, the two angles 176,178, are cut into thesecond sleeve 20B in the range of about 40° to about 170°, or about 80°to about 130°, preferably about 90° from the longitudinal axis 22B ofsecond sleeve 20B proximal end 160. In one embodiment, the two angles176 and 178 are cut into the second sleeve 20B for a distance betweenabout 0.01 inch and about 0.05 inch, preferably about 0.04 inch into thesleeve 20A as measured along the perpendicular axis 24B. The secondsleeve 20B is trimmed along the longitudinal axis 22B from the proximalend 160 to the angle 176 and from the proximal end 160 to the angle 178.In general, the amount of the second sleeve 20B that is trimmed alongthe longitudinal axis 22B from the proximal end 160 to each respectiveangle, 176 and 178, is substantially the same. The second sleeve 20Bsecond lumen 185B includes a tube-like structure. Referring now to FIGS.3E and 3F, after the tube-like second sleeve 20B is trimmed, theproximal end 160 includes a top section and a bottom section 160B.Referring now to FIG. 3F, the longitudinal axis 22B of second sleeve 20Bfrom the angle 176 and the angle 178 to the end of bottom section 160Bmay measure between about 2.0 inches to about 14.0 inches, preferablyabout 10.0 inches. The top section is trimmed along the perpendicularaxis 24B of sleeve 20B, from the legs of angles 176 and 178, which areat an angle to the longitudinal axis 22B of sleeve 20B.

As shown in FIGS. 3D, 3F, and 3G, the bottom section 150B of the firstsleeve 20A is placed at about a 90° angle relative to the longitudinalaxis 22A of the first sleeve 20A. Similarly, the bottom section 160B ofthe second sleeve 20B is placed at about a 90° angle relative tolongitudinal axis 22B of the second sleeve 20B. The sleeves 20A and 20Bare aligned in proximity to one another such that the bottom sections150B and 160B of sleeves 20A and 20B, respectively, face one another.

Referring now to FIG. 3I, the bottom sections 150B and 160B are joinedto one another by adhesive, staples, heat bonding or other means knownto the skilled person to form hinge 200. In one embodiment, a clip (notshown) may be employed to join bottom sections 150B and 160B, which actas hinge sections when they form hinge 200. As shown in FIG. 3H, theproximal end 154 of first sleeve 20A and the distal end 164 of thesecond sleeve 20B are positioned on opposite ends of the envelope 20formed by sleeve 20A and sleeve 20B. The length of envelope 20, measuredalong the longitudinal axis 22 from proximal end 154 to the distal end164, ranges between about 4.0 inches to about 28.0 inches, or betweenabout 12.0 inches and about 24.0 inches, most preferably 20.0 inches.

Referring again to FIG. 3I, the tongue 155 of the first sleeve 20A istucked inside the lumen 185B of the second sleeve 20B. The tongue 155 issized and shaped so that it fits within the lumen 185B of the secondsleeve 20B. When the tongue 155 is tucked inside lumen 185B, the sling10 enclosed within envelope 20 is shielded by the tongue 155 in theregion 255 of the envelope 20 corresponding to the tongue 155. Forexample, in embodiments where the envelope 20 is employed to implant amid-urethral sling 10, the tongue 155 of the envelope 20 prevents damageto the sling 10 caused by, for example, patient tissue rubbing againstthe sling 10 in the region of the envelope 20 corresponding to thetongue 155 during sling 10 placement. Also, the tongue 155 preventsabrasion to patient tissue caused by the sling 10 during envelope 20placement.

Referring to FIGS. 3A and 3D, in another embodiment, two sleeves 20A,each having a tongue 155, are provided. The two sleeves 20A arepositioned so that their tongues 155 face one another and are positionedon the same plane. Each sleeve 20A tongue 155 is configured to fitinside the lumen 185A of sleeve 20A that it faces. According to thisembodiment, the two sleeve 20A tongues 155 combine to provide thedesired coverage and protection of the sling 10 enclosed within theenvelope 20. In one illustrative embodiment, referring, still to FIGS.3A and 3D, two sleeves 20A having a perpendicular axis 24A measuringabout 1 inch may be identically cut to provide a tongue 155 width thatmeasures about 0.5 inch, as measured from angle 178 along theperpendicular axis 24A. The two sleeves 20A are positioned so that theirtongues 155 face one another and are positioned on the same plane. Eachof the two sleeves 20A tongue 155 is inserted into the lumen 185A of thesleeve 20A that it faces and the two tongues 155 protect a sling 10enclosed by the two sleeves 20A when they form an envelope 20.

As shown in FIGS. 3A and 3G-3I, and as described above, sleeves 20A and20B are joined to form envelope 20. The first lumen 185A and the secondlumen 185B form the single lumen 185 of the envelope 20. The joinedbottom sections 150B and 160B of sleeves 20A and 20B act as hingesections to form hinge 200 of envelope 20. Various methods may beemployed to join bottom sections 150B and 160B, for example, heatbonding, adhesives, or staples. In one embodiment, a clip (not shown)may be employed to join bottom sections 150B and 160B, forming hinge200. The length of hinge 200 may range between about 2.0 inches to about14.0 inches in length. The hinge 200 may be trimmed to a shorter lengththat may be grasped by the operator during the method of delivering theimplant assembly, described below. One or both of sleeves 20A and 20B ofenvelope 20 may be made from a composite of two or more materials.

In another aspect, the invention is a method for delivering an implantassembly 120 to a patient's body. Referring to FIGS. 3H-3I, the sling 10is placed within the envelope 20 as is described above with reference toFIGS. 1J and 1K. At least a portion of the sling 10 is enclosed withinthe envelope 20 and in one embodiment, the envelope 20 enclosessubstantially all of the sling 10. With reference to FIG. 3A, in anotheraspect the invention is a method for positioning an implant, forexample, a sling 10 at an anatomical site in the body of a patient.According to one embodiment of this method of the invention, theoperator positions the envelope 20 enclosing sling 10, at the anatomicalsite, for example, the urethra 999 or bladderneck.

With reference to FIGS. 3A and 3I, the operator grasps hinge 200 andcuts hinge 200 near position 200A. Position 200A is the area of thehinge 200 adjacent implant sling 10, where bottom sections 150B and 160Bof sleeves 20A and 20B are not sealed. In one embodiment, the operatorcuts one bottom section, 150B or 160B, at position 200A to free it fromthe other bottom section 150B or 160B. In another embodiment, theoperator cuts hinge 200 at position 200A and thereafter withdraws hinge200 via the vagina. In one embodiment, the joined bottom sections 150Band 160B of hinge 200 are pulled apart. In another embodiment, theoperator unfastens and withdraws a clip (not shown) surrounding thebottom sections 150B and 160B, which act as hinge sections, that formhinge 200.

The operator next grasps tab 208 and pulls tab 208 and the attachedsleeve 20A in the direction indicated by arrow 289, withdrawing the tab208 and attached sleeve 20A. Thereafter, the operator grasps tab 218 andpulls tab 218 and the attached sleeve 20B in the direction indicated byarrow 389, withdrawing the tab 218 and attached sleeve 20B. The sling 10previously enclosed by the envelope 20 is thereby exposed and the sling10 remains inside the body of the patient at the anatomical site wherethe sling 10 was positioned by the operator, for example, at theanatomical site of the urethra 999.

FIG. 4 illustrates the envelope 20 having the tongue 155, as describedabove with reference to FIGS. 3A-3I, further including the first guidetube 350A and the second guide tube 350B, as described above withreference to FIGS. 2A-2C. The guide tubes 350A and 350B may provide theoperator a mechanical advantage and simplify grasping and withdrawingthe sleeves 20A and 20B during the surgical procedure to position thesling 10 at an anatomical site in the body of a patient, for example, atthe urethra 999.

In another aspect, the invention includes an assembly 120 for deliveringan envelope 20 and an implant sling 10 to an anatomical site in the bodyof a patient. In one embodiment, shown in FIG. 5A the assembly 120includes the envelope 20 including two or more sleeves 20A, 20B, one ormore guide tubes 350A, 350B, and a scaffold 305. Referring also to FIG.5I, the scaffold 305 joins sleeve 20A and 20B to form envelope 20. Inone embodiment, the scaffold 305 has a fold 310 that is positioned, forexample, between sleeves 20A and 20B. In one embodiment the fold 310positioned between sleeves 20A and 20B forms a hinge 200. The scaffold305 simplifies placement and/or withdrawal of the envelope 20 frominside the body of the patient and maintains the integrity of theenvelope 20.

Referring now to FIGS. 5A-5G, the scaffold 305 generally is a flat pieceof material that is dimensioned to fit within the lumens 185A and 185Bof the sleeves 20A and 20B to join the sleeves 20A and 20B that form theenvelope 20. The scaffold 305 may be fabricated from one or morematerials such as, for example, polypropylene, polyethylene, polyester,polytetrafluoroethylene, TYVEK®, MYLAR®, and co-polymers thereof as wellas one or more dissolvable materials or one or more absorbent materialssuch as, for example, a sponge-like material such as polyglycolic acid,polylactic acid and other suitable absorbable materials. The scaffold305 may be firm or rigid, but preferably, it is flexible. Referring toFIG. 5C, the scaffold thickness may range from about 1 mil to about 6mil, preferably about 3.5 mils. Referring to FIG. 5B, the scaffold 305longitudinal axis 32 is measured from the scaffold 305 first side 305Ato the scaffold second side 305B. The longitudinal axis 32 rangesbetween about 4 inches and about 60 inches, preferably being about 23inches. The scaffold perpendicular axis 34 ranges between about 0.2inches to about 2 inches, preferably between about 0.4 inches to about0.8 inches, preferably being about 0.6 inches.

FIGS. 5A and 5D illustrate the scaffold 305 having a fold 310. The fold310 may be employed to position an implant enclosed by envelope 20. Thefold 310 may aid in withdrawal of the scaffold 305 or withdrawal of theenvelope 20 after assembly 120 placement (described below). In oneembodiment, a portion of the scaffold 305 longitudinal axis 32 ispinched to form a fold 310. Adhesives, staples, heat bonding or otherbonding means known to the skilled person may be employed to maintainthe fold 310 in the scaffold 305. The fold 310, as measuredperpendicular to the longitudinal axis 32 of scaffold 305, ranges fromabout 0.5 inches to about 6 inches, preferably 2 inches long. In anotherembodiment, two or more pieces of material may be bonded together byadhesives, staples, heat bonding or other bonding means known to theskilled person to make scaffold 305 and the two pieces of material mayform a bond joint to provide the fold 310.

Referring to FIG. 5A, the scaffold 305 thickness and the material usedto manufacture the scaffold 305 may be selected to provide the envelope20 with integrity appropriate for the surgical procedure, e.g., towithstand the forces imposed on the envelope 20 when placing the sling10 in the patients body. In another embodiment, the scaffold 305material may be selected because it forms a strong bond with the sleeve20A, 20B or the guide tube 350A, 350B. The scaffold 305 material may bethe same or different than the material used to manufacture the sleeves20A, 20B. The scaffold 305 may be bonded inside the lumens 185A and 185Bof the sleeves 20A and 20B by adhesives, suturing, heat bonding or anyother means known to the skilled person. In one embodiment, the scaffold305 is bonded to a portion of the sleeve 20A inside the lumen 185A.

Referring to FIG. 5A, in one embodiment according to the invention, theassembly 120 includes an envelope 20 including a first sleeve 20A, asecond sleeve 20B, the scaffold 305 and a sling 10. Guide tubes 350A and350B are disposed on the proximal end 154 and the distal end 164 of theenvelope 20. Referring now to FIG. 5E, the sleeve 20A may have a tongue155 prepared in the same manner as was described with respect to theFIGS. 3B-3D. Referring still to FIG. 5E, the bottom section 150B,described in relation to FIG. 3D, is removed by trimming the bottomsection 150B along the perpendicular axis 24A of sleeve 20A. In oneembodiment, the bottom section 150B of sleeve 20A is trimmed along theperpendicular axis 24A from about the angle 176 vertex to about theangle 178 vertex.

Referring to FIG. 5F, the second sleeve 20B of the envelope 20 shown inFIG. 5A is illustrated. The second sleeve 20B has an inner surface 30,an outer surface 40, a proximal end 160, and a distal end 164. Thesecond sleeve 20B is a tube-like structure including a second lumen185B. The length of the second sleeve 20B between the proximal end 160and the distal end 164, along the longitudinal axis 22B, measuresbetween about 2.0 inches and about 14.0 inches, preferably being about10.0 inches. The perpendicular axis 24B of second sleeve 20B measuresbetween about 0.2 inches to about 2.0 inches, preferably between about0.4 inches and about 0.8 inches, preferably about 0.6 inches.

As illustrated in FIGS. 5G and 5I, the first side 305A of scaffold 305is inserted into lumen 185A and the second side 305B of scaffold 305 isinserted into lumen 185B. The scaffold 305 may be bonded to a portion oralong the entire length of the lumens 185A and 185B of sleeves 20A and20B, respectively, by employing adhesive, staples, heat bonding or othermeans known to the skilled person. In another embodiment, the scaffold305 is simply positioned inside the lumens 185A and 185B of the sleeves20A and 20B without being bonded to the sleeves 20A or 20B of envelope20. One or both of sleeves 20A and 20B may be made from a composite oftwo or more materials.

In one embodiment, referring now to FIGS. 5E and 5F, sleeve 20A,measured from the proximal end 154 to the end of the tongue 155 alongthe longitudinal axis 22A measures about 10.75 inches, with the lengthof tongue 155 measuring about 1 inch, and the longitudinal axis 22B ofsleeve 20B measures about 9.75 inches. Referring again to FIG. 5I, inone embodiment, the scaffold 305 joins sleeves 20A and 20B to formenvelope 20 and the sling 10 is positioned inside the lumen 185 ofenvelope 20. When the sleeve 20A tongue 155 is tucked inside the lumen185B of sleeve 20B, the envelope 20 measures about 19.5 inches. In anembodiment where sling 10 measuring about 14 inches long is enclosed byenvelope 20, about 5.5 inches of space of lumen 185 is free from thesling 10. The proximal end 154 and the distal end 164 of envelope 20 mayeach extend up to about 2 inches beyond the sling 10.

Referring now to FIGS. 5F and 5I, the scaffold 305 may be used to jointwo sleeves 20B and 20B that do not have a tongue 155. In suchembodiments, a portion of the sling 10 enclosed by the envelope 20 maybe exposed.

One or both of sleeves 20A and 20B of envelope 20 may be made from acomposite of two or more materials. The scaffold 305 may or may not havea fold 310. Referring now to FIG. 5A, the scaffold 305 may be used tojoin sleeves 20A and 20B with or without guide tubes 350A and 350B. Forexample, in some embodiments, the scaffold 305 joins sleeves 20A and 20Bhaving tabs (not shown).

In another illustrative embodiment according to the invention, referringagain to FIG. 5A, the sling 10 is placed within the lumen 185 ofenvelope 20 after sleeves 20A and 20B are joined when scaffold 305 ispositioned between the sleeves 20A and 20B, but prior to guide tubes350A and 350B being joined to the envelope 20. A first guide tube 350Aand a second guide tube 350B are described above with reference to FIGS.2A-2C. Tabs 208 and 218 described with reference to FIGS. 1A and 3A mayalternatively be joined to the envelope 20 proximal end 154 and distalend 164, respectively. The implant, for example a sling 10, may beinserted into the lumen 185 of envelope 20 manually and/or with the aidof a grasping device or with the aid of a placement fork 170 describedabove with reference to FIG. 1J. The envelope 20 may enclose at least aportion of the sling 10. In one embodiment, referring to FIG. 5I, theenvelope 20 includes a tongue 155, which may be employed to overlay orprotect the sling 10 enclosed within envelope 20.

Referring to FIGS. 1J and 5I, in one embodiment, the sling 10 insidelumen 185 lies between scaffold 305 and the top surfaces, 250A and 260Aof the sleeves 20A and 20B of envelope 20. In another illustrativeembodiment, at least the first end 305A of scaffold 305 is placed insideof the first lumen 185A of sleeve 20A and the sling 10 is placed withinthe first lumen 185A of the first sleeve 20A manually and/or with theaid of a grasping device or with the aid of a placement fork 170.Thereafter, sleeve 20B is joined with sleeve 20A by inserting at leastthe second end 305B of scaffold 305 inside the lumen 185B of sleeve 20Bto form envelope 20. In one embodiment the first end 305A and the secondend 305B of scaffold 305 are bonded inside the lumens 185A and 185B ofthe sleeves 20A and 20B, respectively. The remaining portion of sling 10may be placed within the second lumen 185B of sleeve 20B. Optionally,the remaining portion of sling 10 may be placed within the second lumen185B of sleeve 20B prior to or after forming a fold 310 within scaffold305.

The operator may employ the assembly 120 of the invention illustrated inFIG. 5A to position the sling 10 at an anatomical site in the body of apatient. The operator will employ the first and second guide tubes 350Aand 350B to position the envelope 20 enclosing sling 10 at an anatomicalsite in the body of a patient with the aid of a delivery device.Suitable delivery devices may be used to position the envelope 20 of theassembly 120 enclosing at least a portion of an implant according to aplurality of surgical approaches, for example, according totransvaginal, transabdominal (e.g., percutaneous), supra-pubic,pre-pubic, or transobturator approaches. The operator positions theenvelope 20 enclosing sling 10 at the anatomical site, for example, theurethra 999 or bladderneck.

With continued reference to FIG. 5A, the operator grasps the scaffold305 that is between the sleeves 20A and 20B and then cuts the scaffold305. In one illustrative embodiment, the operator cuts and withdraws thefold 310 within the scaffold 305. Next, the operator grasps the firstguide tube 350A and pulls guide tube 350A, the attached sleeve 20A, anda portion of scaffold 305 in the direction indicated by arrow 289,withdrawing the guide tube 350A, attached sleeve 20A and a portion ofscaffold 305 from the patient's body. Thereafter, the operator graspsthe second guide tube 350B and pulls guide tube 350B, the attachedsleeve 20B and a portion of scaffold 305 in the direction indicated byarrow 389, withdrawing the guide tube 350B, the attached sleeve 20B anda portion of scaffold 305 from the patient's body. In one embodiment,the guide tubes 350A and 350B provide the operator with a mechanicaladvantage simplifying grasping the sleeves 20A and 20B during thesurgical procedure. The sling 10 previously enclosed by the envelope 20is thereby exposed and remains inside the body of the patient at theanatomical site where the sling 10 was positioned by the operator, forexample, at the anatomical site of the urethra 999.

Referring still to FIG. 5A, in another illustrative embodiment, theoperator cuts envelope 20 at position 437A and withdraws the first guidetube 350A and a portion of envelope 20. The operator cuts envelope 20 atposition 437B and withdraws the second guide tube 350B and a portion ofthe envelope 20. According to this embodiment, the scaffold 305 may bebonded to the lumens 185A and 185B of envelope 20. The operator cuts thescaffold 305 and grasps and withdraws the first envelope 20A and aportion of scaffold 305 from the patient. Thereafter, the operatorgrasps and withdraws the second envelope 20B and a portion of scaffold305 from the patient. The sling 10 previously enclosed by the envelope20 is thereby exposed and remains inside the body of the patient at theanatomical site where the sling 10 was positioned by the operator, forexample, at the anatomical site of the urethra 999.

In another embodiment, referring still to FIG. 5A, the guide tube 350A,the proximal end 154 of sleeve 20A and the scaffold 305 first end 305Aare bonded together. Similarly, the guide tube 350B, the distal end 164of sleeve 20B and the scaffold 305 second end 305B are bonded together.The operator cuts and withdraws guide tubes 350A and 350B at positions437A and 437B on envelope 20. Thereafter, the operator grasps scaffold305 between the sleeves 20A and 20B and intravaginally withdraws thescaffold 305 from the envelope 20. Optionally, the scaffold 305 fold 310is grasped. Finally, the operator grasps and withdraws the first sleeve20A and thereafter grasps and withdraws the second sleeve 20B. The sling10 previously enclosed by the envelope 20 is thereby exposed and thesling 10 remains inside the body of the patient at the anatomical sitewhere the sling 10 was positioned by the operator, for example, at theanatomical site of the urethra 999. Alternatively, after cutting theenvelope 20 at positions 437A and 437B and withdrawing guide tubes 350Aand 350B, the operator first grasps and withdraws the first sleeve 20A,then grasps and withdraws the second sleeve 20B, and finally grasps andwithdraws the scaffold 305. In one embodiment, when the sleeves 20A and20B are withdrawn from the patient prior to the scaffold 305, thescaffold 305 acts as a slide that enables the sleeves 20A and 20B todisengage from the envelope 20.

Referring to FIGS. 6-7, the implant assembly 120, and more specifically,the envelope 20 of the assembly 120 has a proximal end 154 and a distalend 164 and the envelope 20 encloses at least a portion of the implant,for example a sling 10 for treatment of female urinary incontinence. Theimplant sling 10 may be made from a mesh. Referring now to FIG. 6, inone embodiment, the envelope 20 includes a single sleeve 20C.

In one illustrative embodiment, the sling 10 includes a de-tangedmid-length portion 244, which has end points 249A and 249B, and twotanged end-length portions 248A and 248B. Suitable implant slings 10include the de-tanged slings such as the slings described in, forexample, U.S. Ser. No. 10/092,872 filed Mar. 7, 2002, the entirety ofwhich is incorporated by reference herein. The two tanged end-lengthportions 248A and 248B extend from the end points 249A, 249B of thede-tanged mid-length portion 244 to sling ends 252A and 252B,respectively. The two tanged end-length portions 248A and 248B are, in apreferred embodiment, of substantially equal length, such that thede-tanged mid-length portion 244 is substantially centered along thelong axis of the sling 10.

The envelope 20 includes a first sleeve surface 256 extending along thelong axis of the envelope 20 and a second sleeve surface 258 disposed onthe opposite side of the envelope 20 from the first sleeve surface 256.In one embodiment, the first sleeve surface 256 has at least onediscontinuity 264. Referring to FIG. 6, for example, in one embodiment,the discontinuity 264 in the first sleeve surface 256 is, for example, agap 268, indicated by double-ended arrows 269. The gap 268 is defined bya first sleeve end point 276A and a second sleeve end point 276B.Referring now to FIG. 7, in an alternative embodiment, the envelope 20includes two discontinuities 264 in the first sleeve surface 256, forexample, slit-shaped apertures 272A, 272B. In still other embodiments,the first sleeve surface 256, or the second sleeve surface 258, mayinclude any number of discontinuities 264.

Referring to the embodiment illustrated in FIG. 6, a first region 273Ain the first sleeve surface 256 extends from the proximal end 154 to theend point 276A and a second region 273B in the first sleeve surface 256extends from the distal end 164 to the end point 276B. The separation ofthe first region 273A from the second region 273B by the gap 268 allowsthe envelope 20 to be removed when the physician cuts the second sleevesurface 258. The gap also aids in removal of the envelope 20 bypreventing friction between the first region 273A and the second region273B that might otherwise occur if the regions 273A and 273B overlapped.Friction between the regions 273A and 273B would make the process ofremoving the envelope 20 from about the sling 10 more difficult. The gap268 eliminates the possibility that the first region 273A and the secondregion 273B may stick to one another.

The gap 268 in the first sleeve surface 256 may be made in a variety ofways. As an example, the envelope 20 is flattened and a rectangularwindow, having width substantially equal to the width of the firstsleeve surface 256, is cut out of a mid-length section of the firstsleeve surface 256.

Referring still to the embodiment illustrated in FIG. 6, the de-tangedmid-length portion 244 of the sling 10 is preferably in alignment with,and therefore exposed at, the gap 268. In other words, end points 249A,249B of the de-tanged mid-length portion 244 preferably coincide withthe first sleeve end point 276A and the second sleeve end point 276B,respectively.

Referring to the embodiment illustrated in FIG. 7, the sling 10 is shownto be at least partially enclosed by the envelope 20. The sling 10 exitsthe envelope 20 at one slit-shaped aperture 272A and 272B, and re-entersthe envelope 20 at the other slit-shaped aperture 272B and 272A.Preferably, the end points 249A and 249B of the de-tanged mid-lengthportion 244 coincide with the slit-shaped apertures 272A and 272B of thefirst sleeve surface 256, such that the de-tanged mid-length portion 244of the sling 10 is located outside the envelope 20, between theslit-shaped apertures 272A and 272B, and the two tanged end-lengthportions 248A and 248B are enclosed within the envelope 20.

Variations, modifications, and other implementations of what isdescribed herein will occur to those of ordinary skill in the artwithout departing from the spirit and the scope of the invention.Accordingly, the invention is not to be defined only by the precedingillustrative description of certain embodiments.

1-63. (canceled)
 64. A method for delivering an implant to an anatomicalsite in the body of a patient, the method comprising the steps of:providing an assembly comprising an envelope, said envelope comprisingat least a first sleeve and a second sleeve, said sleeves configured toenclose at least a portion of said implant, one of said first sleeve andsaid second sleeve comprises a tongue, wherein said tongue overlaps saidimplant; positioning said implant at said anatomical site; andwithdrawing said envelope from the patients body.
 65. The method ofclaim 64 wherein each sleeve further comprises a hinge section, thehinge section of one sleeve coupled to the hinge section of the othersleeve.
 66. The method of claim 65 further comprising the steps of:cutting said hinge sections, separating said first sleeve from saidsecond sleeve and withdrawing said sleeves from the patient's body. 67.A method for delivering an implant to an anatomical site in the body ofa patient, the method comprising the steps of: providing an assemblycomprising an envelope, said envelope comprising at least a first sleeveand a second sleeve, said sleeves configured to enclose at least aportion of said implant; providing a scaffold, said scaffold couplingsaid first sleeve and said second sleeve; positioning said implant atsaid anatomical site; and withdrawing said envelope from the patientsbody.
 68. The method of claim 67 wherein said scaffold further comprisesa fold to form a hinge between the first and second sleeves.
 69. Themethod of claim 67 further comprising the steps of: cutting saidscaffold and separating said first sleeve and said second sleeve; andwithdrawing said scaffold and said sleeves from the patient's body. 70.An assembly for delivering an implant to an anatomical site in the bodyof a patient, the assembly comprising: an envelope comprising a firstsleeve section and a second sleeve section interoperating to enclose atleast a portion of said implant; a tab on an end of said first sleevesection and passed through said first sleeve section to a first end ofsaid envelope; and a tab access located at said first end of saidenvelope for accessing said tab.
 71. The assembly of claim 70 furthercomprising a tab on an end of said second sleeve section and passedthrough said second sleeve section to a second end of said envelope; anda tab access located at said second end of said envelope for accessingsaid tab.
 72. The assembly of claim 70 wherein said envelope furthercomprises an external tab located at the end of the first sleeve sectionfor positioning said envelope inside the body of a patient.
 73. Theassembly of claim 70 wherein said envelope comprises a visual indicationmark disposed on a surface of said envelope for aiding in positioningsaid envelope.
 74. The assembly of claim 70 wherein each of said firstand second sleeve sections are separate sleeves.
 75. The assembly ofclaim 74 wherein each of said first and second sleeve sections is thesame length.
 76. The assembly of claim 74 wherein said at least saidfirst and second sleeve sections overlap to enclose at least a portionof said implant.
 77. The assembly of claim 70 wherein each of said firstand second sleeve sections comprise at least one hinge section.
 78. Theassembly of claim 77 wherein said hinge section of the first sleevesection is coupled to said hinge section of the second sleeve section toform a hinge.
 79. The assembly of claim 70 wherein said envelopecomprises a tearable region.
 80. The assembly of claim 79 wherein saidtearable region includes a tab on the first sleeve section.
 81. Theassembly of claim 79 wherein said tearable region comprises a pluralityof apertures.
 82. The assembly of claim 70 wherein said envelopecomprises a plurality of cuts.
 83. The assembly of claim 70 wherein saidenvelope is made from a tearable material.
 84. The assembly of claim 70wherein said envelope is made from a material with a linear molecularorientation.
 85. A method for delivering an implant to an anatomicalsite in the body of a patient, the method comprising the steps of:providing an assembly comprising an envelope comprising a lumen sized toenclose at least a portion of said implant, an internal tab, saidinternal tab being joined to said envelope, and a tab access, whereinsaid internal tab is accessible through said tab access to position saidimplant in the body of the patient; and positioning said assembly atsaid anatomical site in the patient's body.
 86. A method for deliveringan implant to an anatomical site in the body of a patient, the methodcomprising the steps of: providing an assembly comprising an implant andan envelope, said envelope comprising at least two sleeves, said sleevesconfigured to enclose at least a portion of said implant, wherein eachsleeve further comprises a hinge section, said hinge section of onesleeve coupled to said hinge section of the other sleeve; positioningsaid implant at said anatomical site in the patient's body.
 87. Themethod of claim 86 further comprising the steps of: cutting said hingesection and separating said sleeves; and withdrawing said sleeves fromthe patient's body.
 88. A method for delivering an implant to ananatomical site in the body of a patient, the method comprising thesteps of: positioning an implant at an anatomical location; pulling atab in a first sleeve section to tear a portion of an envelope away fromthe implant; and intravaginally pulling on a hinge on the implantsubsequent to pulling on said tab to withdraw all or a portion of saidenvelope from the body via the vagina.
 89. The method of claim 88further comprising the steps of: accessing said tab on the first sleevesection via a tab access on the first sleeve section prior to pullingsaid tab.